Kornimate/medical-research-clean huggingface dataset:
phase 3 study of tramadol hydrochloride/acetaminophen sr tab. & tramadol hydrochloride/acetaminophen tab. in low back pain patients

Conditions: Low Back Pain

Summary: the purpose of this study is to evaluate effectness of tramadol hydrochloride/acetaminophen sr tab. and tramadol hydrochloride/acetaminophen tab. in patients with low back pain.


Eligibility criteria:
inclusion criteria: 1. adult males/females aged over 20 years 2. patient with low back pain who needs analgesic administration 3. patient with low back pain who correspond with class 1, 2 in quebec task force classification 4. pain vas value over 40 mm 5. subjects who voluntarily or legal guardian agreed with written consent exclusion criteria: 1. patients with severe gi tract disorder, liver disease, renal disease, heart disease, hypertension 2. patients with obvious secondary cause(metastatic cancer, fracture, infectious disease) 3. patients who had taken back surgery within 24 weeks from the screening point 4. patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point 5. patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point

Keywords: low back pain wontran wontran sr tab. tramadol hydrochloride/acetaminophen
efficacy study of dx-88 (ecallantide) to treat acute attacks of hereditary angioedema (hae)

Conditions: Hereditary Angioedema (HAE)

Summary: the purpose of this study is to evaluate the efficacy and safety of dx-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.

this is a randomized placebo-controlled trial. the study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. this study is conducted under special protocol assessment with the fda and is designed to provide pivotal efficacy data on ecallantide. these data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. efficacy and safety of ecallantide will be evaluated in this study.

Eligibility criteria:
inclusion criteria: * 10 years of age or older * executed informed consent * documented diagnosis of hae (type i or ii) * presentation at the site within 8 hours of patient recognition of an moderate to severe hae acute attack exclusion criteria: * receipt of an investigational drug or device, within 30 days prior to study treatment * receipt of non-investigational c1-inh within 7 days of treatment * receipt of dx-88 (ecallantide) within 3 days prior to study treatment * diagnosis of acquired angioedema (aae), estrogen-dependent angioedema or drug-induced angioedema (including angiotensin-converting enzyme inhibitor induced angioedema) * pregnancy or breastfeeding
provigil in conjunction with ssris for the treatment of mild or moderate depression with attendant symptoms of sleepiness and fatigue.

Conditions: Major Depression; Mental Health

Summary: the main purpose of this study is to determine if provigil® (modafinil) at a dose of 200 mg once daily is safe and effective for treating symptoms of sleepiness and fatigue associated with major depressive disorder when added to a ssri.

approximately 100 male and female outpatients, who are between the ages of 18 and 65, will be enrolled at four sites in the united states. this study consists of two parts. the first part consists of 6 weeks of open label treatment with a selected ssri \& double blind treatment with provigil or placebo (inactive medication). after the six week double blind treatment phase all patients will enter a four week open label treatment phase with provigil. the dose of provigil is not to exceed 400 mg and cannot be less than 100 mg per day. they will continue taking the prescribed ssri.

Eligibility criteria:
inclusion criteria: * major depressive disorder * madrs score ≥ 15 at both screen \& baseline. * significant fatigue as evidenced by fss ≥4 at both screen \& baseline. * excessive sleepiness as evidenced by ess ≥ 10 at both screen \& baseline. exclusion criteria: * treatment refractory depression * serious or unstable medical condition. * pregnancy * primary diagnosis of another axis i or ii disorder * alcohol or substance abuse or dependence within the past 12 months.

Keywords: depression
cognitive training for emotion regulation in psychotic disorders

Conditions: Schizophrenia; Schizo Affective Disorder

Summary: the current study examines the efficacy of a cognitive training intervention for improving emotion regulation in psychotic disorders. it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.

psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and present major challenges to our health care system. difficulties with emotion regulation (i.e., the ability to control the emotion response using strategies) significantly predict the development and maintenance of psychotic symptoms and poor community-based functional outcomes. recent neuroimaging research indicates that hypofrontality may underlie these deficits. unfortunately, there is no accepted technique for remediating these emotion regulation abnormalities in psychotic disorders. recent advances from the field of cognitive neuroscience provide hope for a resolution to this critical unmet need in psychotic disorder therapeutics, demonstrating that brief computerized cognitive training interventions are capable of improving emotion regulation ability by targeting neural activation in the prefrontal cortex. the goal of the proposed project is to determine whether an emotional working memory cognitive training program is effective for remediating emotion regulation abnormalities and associated clinical outcomes in people with psychotic disorders. outpatients with psychotic disorders will be randomly assigned to either an emotional working memory training (n = 35) or placebo (p: n = 35) cognitive training control intervention delivered via an app on a smart phone for 30 days. the primary aim is to determine whether the emotional working memory intervention successfully engages the target mechanism and enhances prefrontal activation on a non-trained emotion regulation transfer task beyond a pre-specified effect size criterion. results will also be used to determine the treatment duration (15 vs. 30 days) that most effectively and efficiently improves the target.

Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual fifth edition diagnosis of schizophrenia or schizoaffective disorder * 18-60 years old * speaks english * premorbid intelligence quotient \> 70 * clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months. exclusion criteria: * history of intellectual disability or neurological disorder * history of traumatic brain injury with loss of consciousness \> 10 minutes or behavioral sequelae * substance use disorder within the last 6 months (other than nicotine) * 4) endorsement of mri exclusion factors
the percent of aki occurred in patient with comorbidities undergoing colonoscopy

Conditions: Acute Kidney Injuries

Summary: observation the percent aki in patient with comorbidities undergoing colonoscopy

recording the data of the patient if there are any comorbidities like dm or htn and observation of the kidney functions before and after the colonoscopy to record the percent of the aki in patient undergoing colonoscopy

Eligibility criteria:
inclusion criteria: * adult patient aged \>18 years old patient with egfr\>30ml/min exclusion criteria: * patient with egfr \<30ml/min patient with serum electrolytes abnormalities patient with heart diseases (uncontrolled heart failure, unstable angina, myocardial infarction, coronary intervention within the previous 3 months) patients with ascites
ta-8995: its use in patients with mild dyslipidaemia (tulip)

Conditions: Dyslipidemia

Summary: the primary objective of this study is to evaluate the efficacy of different doses of ta-8995, a cholesteryl ester transfer protein (cetp) inhibitor, on the elevation of high-density lipoprotein cholesterol (hdl-c) and reduction of low-density lipoprotein cholesterol (ldl-c), alone and in combination with statin therapy. the secondary objectives of this study are to determine the safety and tolerability of ta-8995 in patients with mild dyslipidaemia.


Eligibility criteria:
inclusion criteria: * fasting ldl-c levels \>2.5 mmol/l and \ 0.8 mmol/l, and tg levels \<4.5 mmol/l after run in or washout of existing therapies * not on lipid-altering therapy at screening or on lipid-altering treatment regimens at screening exclusion criteria: * body mass index \>32 kg/m2; * participation in another clinical study involving an investigational or marketed drug within 30 days prior to enrolment (visit 2); * any clinical manifestation of atherosclerotic vascular disease; * diagnosis of type 1 diabetes; * uncontrolled type 2 diabetes: haemoglobin a1c \>8%; * uncontrolled hypertension: sitting systolic blood pressure \>160 mmhg and/or sitting diastolic blood pressure \>90 mmhg; * history of hyperaldosteronism; * active muscle disease or persistent creatine kinase concentration \>3 × the upper limit of normal (uln). one retest will be allowed after 1 week to verify the result;
o2 versus cpap treatment of patients undergoing sipe therapy (octopus)

Conditions: Swimming Induced Pulmonary Edema (SIPE); Pulmonary Edema; Lung Diseases

Summary: in swimming induced pulmonary edema (sipe), there is a lack of knowledge regarding optimal treatment. the present study was designed to assess the benefit of continuous positive airway pressure (cpap) compared to oxygen as a first line treatment of sipe in the out-of-hospital environment.

swimming induced pulmonary edema (sipe) is an unusual condition affecting otherwise healthy swimmers. sipe is characterized by acute onset of dyspnea and cough, excessive sputum and occasionally hemoptysis when swimming in open water. the condition usually resolves spontaneously within 48 hours, but may result in serious illness and require emergency care. case reports describe acute treatment with oxygen alone or in combination with diuretics, beta-agonist-inhalation or continuous positive airway pressure (cpap). evidence for optimal treatment strategy is lacking. this study intends to determine whether oxygen alone or applied together with cpap leads to improvement of oxygen saturation and recovery of patients. the aim is to treat patients on site without involving hospital care. we study a large cohort of approximately 12 000 swimmers during vansbrosimningen, sweden's biggest annual open water event with a yearly incidence of sipe about 0,4%. adult patients clinically diagnosed with sipe are randomly assigned in 2 groups receiving treatment during 20 minutes: (1) oxygen 10l/min or (2) oxygen 10l/min and cpap 7,5 cm h2o. assessment with outcome measures is taken 10 minutes after treatment. primary endpoint: oxygen saturation (%) by pulse oxymetry.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of swimming induced pulmonary edema (sipe) with need of acute treatment (oxygen saturation ≤91%) * 18 years and older * informed consent exclusion criteria: * declined consent * suspected acute coronary syndrome * severe asthma diagnosed together with pulmonary edema where beta-agonist-inhalation is needed prior to treatment of pulmonary edema * hemodynamic instability or decreased consciousness

Keywords: continuous positive airway pressure (cpap) oxygen therapeutics ultrasonography oximetry
safety study of the monoclonal antibody teplizumab (mga031) in subjects with moderate or more severe psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to determine whether teplizumab is safe when administered subcutaneously (by needle under the skin) in subjects with psoriasis. the study will also evaluate how long teplizumab stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it improves psoriasis.

this study will test the hypotheses that therapeutic modulation of t-cell function by teplizumab is well tolerated in subjects with moderate or more severe psoriasis, and that this treatment ameliorates the immunopathology of psoriasis. this study will evaluate the safety, pharmacokinetics (pk), and pharmacodynamics (pd) of subcutaneous (sc) administration for 6 days. once the sc maximum tolerated dose is identified, this dose will be administered to a cohort of subject by intravenous for comparison of pk and pd.

Eligibility criteria:
inclusion criteria: * chronic plaque psoriasis that has been present for more than 6 months and involves at least 10% body surface area (bsa). * baseline ls-pga score of moderate or greater severity. * weight \<= 125 kg (276 lb) and a bsa \<= 2.5 m\^2. exclusion criteria: * clinically significant flare of psoriasis during the 12 weeks before enrollment. * guttate, erythrodermic, palmoplantar, or pustular (von zumbusch) psoriasis * orally administered systemic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks before enrollment. * prior administration of a biologic agent/monoclonal antibody within 12 weeks before enrollment or 5 half-lives of the agent, whichever is greater. * prior otelixizumab, okt®3, or teplizumab. * treatment within the last 30 days with a non-biologic drug or device that has not received regulatory approval for any indication at the time of study entry or are unwilling to forgo experimental treatment other than teplizumab during this study. * treatment with live vaccine within 8 weeks before enrollment or during study; vaccination with an antigen or killed organism during the study, within 8 weeks before enrollment, or 8 weeks after dosing. * evidence of active infection. * positive igm test for hepatitis a. * history of or positive test for hepatitis b, c, or d. * history of or positive test for hiv. * are immunocompromised, have had recent or current serious systemic or local infection, clinical or radiological evidence of active tuberculosis, or evidence of latent tb infection. * history of chronic liver disease, peripheral vascular disease, cerebrovascular disease, cardiovascular disease, or epilepsy. * current serious or unstable illnesses or allergies. * clinically significant laboratory abnormalities. * presence of serological reactivity to teplizumab (in subjects previously treated with therapeutic antibodies). * clinically significant ecg abnormalities.

Keywords: chronic plaque psoriasis psoriatic arthritis
symptom burden and health related quality of life of cancer patients with concurrent heart failure

Conditions: Heart Failure

Summary: to describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (hfref compared to hfpef).

the investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of hf (hfref and hfpef) using the md anderson symptom inventory- heart failure (mdasi-hf) and promis instruments (fatigue, dyspnea, and sleep disturbance). the investigators will also describe and compare the health-related quality of life using the european organization for research and training quality of life questionnaire-core 30 (eortc qlq-c30) and the measure of quality of life short form-12 (sf-12).

Eligibility criteria:
inclusion criteria: * age 18 years and older * individuals with a concurrent solid tumor cancer diagnosis * not receiving active cancer treatment except for those on maintenance (i.e., selective er modulators (serms)\[tamoxifen\], aromatase inhibitors (anastrozole, letrozole, exemestane), ovarian suppression therapy (gnrh agonists \[leuprolide\], androgen deprivation therapy for prostate cancer * completed cancer treatment at least 3 months and up to 3 years before study enrollment. therapy * able to read, speak and consent in english * ability to understand and the willingness to sign a written informed consent document * diagnosis of heart failure, confirmed by echocardiogram, muga, or cardiac catheterization * internet access via smart phone, tablet, a computer, or another device with the capacity to 1) download the fitbit app and 2) complete electronic study assessments via redcap. exclusion criteria: * participants undergoing active cancer treatment. * inability to provide consent in the medical record, such as cognitively impaired individuals.
the impact of texas senate bill 42 on middle school children's level of physical activity

Conditions: Obesity; Body Weight

Summary: the purpose of this study was twofold: 1) to assess awareness of and adherence to texas sb42 among a representative sample of public middle schools in texas; and 2) to assess the impact of sb42 on the frequency of school pe class, the quality of school pe, and prevalence of child self-reported physical activity behaviors and child overweight along the texas-mexico border.

childhood overweight is a significant public health issue in texas. in response to this problem, the 79th texas legislature passed senate bill 42 (sb 42), which promotes healthier school environments in middle schools, in june, 2005. as a result of sb 42, all texas public middle schools must require students to engage in at least 30 minutes of daily physical activity or a total of 135 minutes of physical activity per week, beginning in the 2006-2007 school year. the purpose of this study was to determine the barriers and facilitators of implementation and the ultimate impact of this mandate on school pe, child physical activity, and child overweight in texas public middle schools, and specifically among children living in the lower rio grande valley (lrgv) of south texas. questionnaires with key informants (school principals, pe teachers, and school district pe and health education directors) were conducted in a random sample of middle schools to assess the implementation of sb 42 (2006-2007). in addition, a more detailed evaluation of sb 42 was accomplished with a representative sample of middle schools in the lrgv, a low-income latino area of the state. measurements in the lrgv schools included observed and measured child physical activity, self-reported physical activity behaviors, and child overweight (bmi).

Eligibility criteria:
inclusion criteria: * the study sample consisted of a representative sample of texas public middle schools (112 schools) as well as a representative sample of lower rio grande valley middle schools (17 schools). exclusion criteria: * middle schools that did not participate in the 2004-2005 school physical activity and nutrition project.

Keywords: coordinated school health school health policy evaluation physical activity
rollover protocol continued access to emtricitabine/tenofovir disoproxil fumarate for adults in united states

Conditions: Chronic Hepatitis B

Summary: the objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (ftc/tdf) for an additional 5 years (240 weeks) to adults completing study gs-us-203-0107.


Eligibility criteria:
key inclusion criteria: * complete all end of study visit procedures and pharmacokinetic (pk) substudy (if applicable) for the gs us 203 0107 study. * a negative pregnancy test is required for female individuals at the end of study visit for gs us 203 0107 (unless surgically sterile or greater than two years post-menopausal). * all sexually active female individuals who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study. * male individuals who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: prevention of chronic hepatitis b recurrence post orthotopic liver transplant prevention of chronic hepatitis b recurrence in patients who have undergone orthotopic liver transplant
protein-rich nutritional therapy combined with time-efficient exercise in cancer therapy

Conditions: Cancer; Cancer Cachexia; Inflammation

Summary: this study aims to evaluate the effects of a 12-week protein-rich individualized nutritional therapy combined with different time-efficient exercise programs on overall physical fitness (cardiorespiratory fitness and muscular fitness), inflammation, and muscle mass/body composition in patients with malignant disease undergoing curative or palliative anti-cancer treatment


Eligibility criteria:
inclusion criteria: * malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma, lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or graft-versus-host-disease after bone marrow transplantation * ongoing or planned curative or palliative anti-cancer therapy * ecog-status 0-2 exclusion criteria: * simultaneous participation in other nutritional or exercise intervention trials * bone metastases with high fracture risk * cardiovascular disease * use of anabolic medications * epilepsy * severe neurological or rheumatic diseases * skin lesions in the area of electrodes * energy active metals in body * pregnancy * acute vein thrombosis

Keywords: cancer cachexia cardiorespiratory fitness nutrition protein intake muscular strength body composition high-intensity interval training physical exercise resistance exercise whole-body electromyostimulation